SEND: SEND/dataset variable label mismatch (SE0063) - Remove?

t Troy

on July 31, 2012

I would like to request the removal of validation rule SE0063 ("SEND/dataset variable label mismatch") from the SEND 3.0 ruleset.

There is no stipulation in the SENDIG or SDTM that the SAS XPT file variables' Label field must be populated with the Variable Label from the implementation guide. In addition, this information is redundant with what is already represented in the define.xml.

Troy Smyrnios

Forums: Validation Rule Suggestions

s Sergiy

on August 16, 2012

Hi! Actually this is one of

Hi!

Per our off-line discussion we agreed to keep the rule for the following 2 basic reasons:

1. Actually this is one of the basic SEND conformance requirements according to SEND IG v3.0 (section 3.3 on page 20):

“3.3 CONFORMANCE

Conformance with the SENDIG Domain Models is minimally indicated by:

….

• Using SENDIG-defined variable labels for all standard domains…”

2. The rule is specific to SAS XPORT format. However we believe that the check is valid and no change to IG is needed until a new regulatory submissions data formats will be defined, developed and widely accepted by the industry.

The current and the only data format for regulatory submissions is SAS XPORT v5 format. Therefore most reporting and analysis tools are SAS XPT centric now. In particular most tools use SAS Variable Labels, rather than Variable Names in their data table or reporting view. In most cases by default settings a user sees SAS Variable Labels, but not Names. Sometimes you cannot even switch view settings from Labels to Names (e.g., some versions of JMP). This is a major reason why a consistency in Variable Labels is the same level of standard compliance as Variable Names. Otherwise it will be very confusing for users who review and analyze data in standard format.

Thank you,

Sergiy Sirichenko